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801691

Biomat USA, Inc. — FEI 3003733819

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 2, 2012
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1105254 (NAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946028 (NAI Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 680606 (NAI Wed Sep 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 640977 (VAI Wed Jan 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
3121 CFR 606.20(b)Qualifications of responsible personnel
33321 CFR 640.64(e)Prevention of contamination
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
924321 CFR 630.40(a)Notification